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Trial registered on ANZCTR


Registration number
ACTRN12619000004167
Ethics application status
Approved
Date submitted
10/12/2018
Date registered
8/01/2019
Date last updated
6/09/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mater Mothers Hospital implementation of txt4two
Scientific title
Implementation and evaluation of an mHealth (mobile health) antenatal weight management and healthy lifestyle program
Secondary ID [1] 296816 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
excess gestational weight gain 310703 0
poor diet quality
 310739 0
insufficient physical activity 310740 0
Condition category
Condition code
Diet and Nutrition 309405 309405 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the txt4two program. Txt4two is an evidence based program that incorporates mobile phone text-based messages, video messages and an information website following a goal setting appointment with a dietitian.

Txt4two texts (messages, website and video links) will be sent automatically by text message. Certain text messages will be tailored based on the goals that women indicate in their goal-setting appointment. Some of these messages will also be interactive. Women will receive messages about the developmental stages of their fetus, diet and physical activity information and behaviour change encouragement, weight self-monitoring, weight reporting, and individual goal review. There will be a number of links also sent to videos that women may choose to watch (this will be sent within the content of some text messages). Participants will be able to indicate their preferred frequency of text messages. A maximum of 11 messages may be received in a week (this maximum is fewer in all but one week). This will occur for a maximum of 20 weeks. How long participants are involved in the program is dependent on what gestational age they are when they join the program.
The txt4two text messaging program is not currently available to the public. This has previously been piloted. https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.14552
Dietetic goal setting appointments will be provided in three different modes - Telehealth (a skype-type call with a dietitian), Face to Face (one on one with a dietitian), or in a dietitian-led workshop setting with other expectant mothers. Both the group and face to face appointment are held in the usual location of dietetic care in the hospital’s antenatal clinic. The telehealth appointment will be ‘hosted’ in the same room, but via a skype-like platform endorsed for use in the clinical setting. Women may be at home during this call.

The current website is www.matermothers.org.au/diet and this will be populated with more nutrition in pregnancy related information, including the videos that will be re-recorded for this site. . The nutrition content will be based on the recommendations of the Australian Dietary Guidelines for pregnancy with emphasis on replacement of sugar sweetened beverages, increased fruit and vegetable intake, reduction of discretionary food groups and consumption of regular meals. (The website will be adapted and localised from the study website which is archived at: http://www.webcitation.org/6QR3k6uaM )
Intervention code [1] 313102 0
Prevention
Intervention code [2] 313103 0
Behaviour
Comparator / control treatment
Women with BMI greater than or equal to 25km/m2 will receive care from a dietitian if they are referred to one by a midwife or obstetrician, according to hospital policy and procedures. All women receive a healthy eating in pregnancy resource at their booking (first) antenatal clinic visit. They are also exposed to videos on healthy nutrition in antenatal clinic waiting rooms. When women see a dietitian they will have their dietary intake assessed and will be advised on recommended changes, as required. Follow up bookings will be organised, as required. (They will not receive tailored text messages or be directed to the videos)
Control group
Active

Outcomes
Primary outcome [1] 308352 0
A comparison between intervention groups and prospective control of overall GWG (pre-pregnancy and from booking visit to final weight). The weight outcomes will be assessed from self-reported weight by participants
Timepoint [1] 308352 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Primary outcome [2] 308353 0
A comparison between intervention groups and prospective control of overall proportion of women gaining weight within (or outside) their recommended range (BMI>25 kg/m2, 7-11 ½; BMI>30kg/m2, 5-9kg. The weight outcomes will be assessed from self-reported weight by participants
Timepoint [2] 308353 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Secondary outcome [1] 354704 0
The proportion of women who are willing to take part in the txt4two program. Data on participation from our trial and hospital population will be collected from the hospital database and AIHW data available online.
Timepoint [1] 354704 0
To be assessed at completion of the study
Secondary outcome [2] 354705 0
Participant preference for initial goal setting modality (dietetic face to face, dietetic telehealth, dietetic led workshop). Data on participant preference for goal setting modality will be collected from the hospital database
Timepoint [2] 354705 0
To be assessed at completion of the study.
Secondary outcome [3] 365323 0
A comparison between intervention groups and prospective control of fruit intake (serves/d). The fruit intake outcome will be assessed from self-reported fruit intake by participants on the Fat and Fibre Behaviour Questionnaire.
Timepoint [3] 365323 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Secondary outcome [4] 365324 0
The representativeness of women who are willing to take part in the txt4two program the broader population of Australian mothers. Data on participation from our trial and hospital population will be collected from the hospital database and AIHW data available online.
Timepoint [4] 365324 0
To be assessed at completion of the study
Secondary outcome [5] 365325 0
The representativeness of women who are willing to take part in the txt4two program compared to the broader MMH population, Data on participation from our trial and hospital population will be collected from the hospital database and AIHW data available online.
Timepoint [5] 365325 0
To be assessed at completion of the study
Secondary outcome [6] 365326 0
Recruitment (women engaged in program/women offered enrolment). Data on proportion of women engaged in program versus the number who were offered enrollment will be collected from the hospital database
Timepoint [6] 365326 0
To be assessed at completion of the study.
Secondary outcome [7] 365327 0
Number of messages sent per participant (median and IQR OR mean and SD). Number of text messages sent per participant will be summarised by our automated messaging system.
Timepoint [7] 365327 0
To be assessed at completion of the study.
Secondary outcome [8] 365328 0
Web analytics (website hits on specific pages promoted through program www.matermothers.org.au/diet).
Timepoint [8] 365328 0
To be assessed at completion of the study.
Secondary outcome [9] 365329 0
Number of participant replies to messages . Number of text messages received per participant will be summarised by our automated messaging system.
Timepoint [9] 365329 0
To be assessed at completion of the study.
Secondary outcome [10] 365330 0
A comparison between intervention groups and prospective control of vegetable intake (serves/d). The vegetable intake outcome will be assessed from self-reported vegetable intake by participants on the Fat and Fibre Behaviour Questionnaire.
Timepoint [10] 365330 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Secondary outcome [11] 365331 0
A comparison between intervention groups and prospective control regarding proportion of women meeting fruit intake guidelines (2/d) (%). The fruit intake outcome will be assessed from self-reported fruit intake by participants on the Fat and Fibre Behaviour Questionnaire.
Timepoint [11] 365331 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Secondary outcome [12] 365332 0
A comparison between intervention groups and prospective control regarding proportion of women meeting vegetable intake guidelines (5+/d) (%). The vegetable intake outcome will be assessed from self-reported vegetable intake by participants on the Fat and Fibre Behaviour Questionnaire.
Timepoint [12] 365332 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Secondary outcome [13] 365333 0
A comparison between intervention groups and prospective control on diet quality score
Dietary quality will be calculated from participant scores on the Fat and Fibre Behaviour Questionnaire.
Timepoint [13] 365333 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Secondary outcome [14] 365334 0
A comparison between intervention groups and prospective control on physical activity levels (minutes/week). Physical activity will be assessed using the Pregnancy Physical Activity Questionnaire
Timepoint [14] 365334 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation
Secondary outcome [15] 365335 0
A comparison between intervention groups and prospective control on proportion of women meeting physical activity guidelines. Physical activity will be assessed using the Pregnancy Physical Activity Questionnaire
Timepoint [15] 365335 0
At time of consent to study (between 10-18 weeks of gestation)
36 weeks gestation

Eligibility
Key inclusion criteria
Eligible women will be women who enter pregnancy with a BMI > 25kg/m2 who are receiving publicly-funded antenatal care at the Mater Mothers Hospital for a singleton, live gestation between 10+0-17+6 weeks and who own a mobile phone.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI<25
<10+0 weeks gestation, or greater than 17+6 weeks gestation
Multiple pregnancies

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Control group will be recruited over a three month period. Following this three month period, recruitment will cease for the control group and commence for the treatment group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A previous pilot study of the txt4two study recruited a sample size of 100 women, which was considered sufficient to allow for the estimation of the standard deviation of GWG, a continuous variable, and to provide reliable data on recruitment and intervention delivery parameters required for planning of a larger intervention trial. Based on the ~2kg difference in weight gain from the original study, we need 119 women per group to provide 80% power. Assuming a 10-20% drop out we will recruit 150 women per group. In addition to the 150 women in the prospective control group we plan to recruit 50 women into each delivery modality.
Quantitative data will be analysed with IBM SPSS Statistics v24 (Armonk, NY: IBM Corp). Means and standard deviations (normal distributions), medians and interquartile ranges (IQR) (skewed distributions) or frequencies will be calculated. 2009 IOM GWG guidelines will be used in analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2019
Actual
22/07/2019
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
31/01/2021
Actual
Sample size
Target
300
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12667 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 25089 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 301388 0
Hospital
Name [1] 301388 0
Mater Misericordiae Limited
Country [1] 301388 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Limited
Address
Mater Misericordiae Limited
Level 3, Aubigny Place
Raymond Terrace,
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 301061 0
Individual
Name [1] 301061 0
Dr Shelley Wilkinson
Address [1] 301061 0
Mater Misericordiae Limited
Level 3, Allied Health,
Salmon Building
41 Raymond Terrace,
South Brisbane, QLD, 4101
Country [1] 301061 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302126 0
Mater Misericoridiae Limited Human Research Ethics Committee
Ethics committee address [1] 302126 0
Ethics committee country [1] 302126 0
Australia
Date submitted for ethics approval [1] 302126 0
05/11/2018
Approval date [1] 302126 0
15/03/2019
Ethics approval number [1] 302126 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89206 0
Dr Shelley Wilkinson
Address 89206 0
Mater Misericordiae Limited
Level 3, Allied Health, Salmon Building
Raymond Terrace
South Brisbane,
QLD 4101
Country 89206 0
Australia
Phone 89206 0
+617 3163 7072
Fax 89206 0
Email 89206 0
shelley.wilkinson@mater.org.au
Contact person for public queries
Name 89207 0
Shelley Wilkinson
Address 89207 0
Mater Misericordiae Limited
Level 3, Allied Health, Salmon Building
Raymond Terrace
South Brisbane,
QLD 4101
Country 89207 0
Australia
Phone 89207 0
+617 3163 7072
Fax 89207 0
Email 89207 0
shelley.wilkinson@mater.org.au
Contact person for scientific queries
Name 89208 0
Shelley Wilkinson
Address 89208 0
Mater Misericordiae Limited
Level 3, Allied Health, Salmon Building
Raymond Terrace
South Brisbane,
QLD 4101
Country 89208 0
Australia
Phone 89208 0
+617 3163 7072
Fax 89208 0
Email 89208 0
shelley.wilkinson@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be only be presented in summary format due to assurances given at participant recruitment/consent.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the Pragmatic Implementation of a Digital Health Intervention Promoting Healthy Nutrition, Physical Activity, and Gestational Weight Gain for Women Entering Pregnancy at a High Body Mass Index.2023https://dx.doi.org/10.3390/nu15030588
N.B. These documents automatically identified may not have been verified by the study sponsor.